The FDA plans to launch a new pilot program to improve the efficiency of orphan designation submissions and reviews, Commissioner Scott Gottlieb announced Monday. Source: Drug Industry Daily
HHS Secretary Alex Azar said the FDA plans to expand the use of medication-assisted treatments for opioid addiction and will soon issue two new guidances on the topic. Source: Drug…
The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Source: Drug Industry Daily
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should…
A former Horizon Pharma senior director sued the drugmaker, claiming she was fired for raising concerns about off-label drug promotion at a previous employer. Source: Drug Industry Daily
The EMA’s Committee for Medicinal Products for Human Use recommended five medicines for European Commission approval and six extended indications at its meeting this month. Source: Drug Industry Daily
The European Medicines Agency published a reflection paper on assessing the frailty of elderly patients in clinical trials, recommending the Short Physical Performance Battery assessment for its prognostic value and…
Citing a public health emergency, a group of congressional Democrats called on HHS Secretary Alex Azar to use existing legislative authority to lower the price of hepatitis C virus treatments.…
Taking some opioid painkillers increases the risk of deadly infections, according to an analysis of data from TennCare, Tennessee’s state Medicaid program. Source: Drug Industry Daily
Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Source:…